Trials / Completed
CompletedNCT02780206
Very Low Calorie Diet Weight Loss
Omics Profiling of the Response to Food and Variability of Weight Loss in Medically Supervised Very Low Calorie Diet
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Texas A&M University · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
Understanding how foods and nutrients are digested, absorbed and metabolized when weight is stable and during weight loss induced by very low calorie diet procedure using the technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics ("omics") will enable generation of new hypotheses that could explain the inter-individual differences in weight loss and could lead to optimization and individualization of therapies designed to lose weight.
Detailed description
The overarching hypothesis is that there are baseline, pre- and post-diet combinations of 'omics' signatures in response to food and nutrients that explain the weight loss response of obese subjects to the very low calorie (VLC) diet. In order to address the general hypothesis the following specific aims will be addressed: Specific Aim 1: To test the hypothesis that there is a combination of 'omics' parameters in response to a defined meal that discriminate between morbidly obese subjects. Specific Aim 2: To test the hypothesis that variation in % weight loss to the 2-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal. Specific Aim 3: To test the hypothesis that variation in % weight loss to the 4-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Stable isotope amino acid infusion | such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2018-10-01
- Completion
- 2018-10-01
- First posted
- 2016-05-23
- Last updated
- 2022-02-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02780206. Inclusion in this directory is not an endorsement.